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ToRsemide for pOstpartum HYpertension (TROPHY)

Primary Purpose

Preeclampsia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Torsemide
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preeclampsia focused on measuring Preeclampsia, puerperium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postpartum women at ≥ 18 years of age
  • Antepartum/intrapartum or within 24 hours postpartum diagnosis of either:
  • Preeclampsia
  • Preeclampsia with severe features
  • Preeclampsia superimposed to chronic hypertension

Exclusion Criteria:

  • Chronic hypertension without superimposed preeclampsia
  • Gestational hypertension
  • Urine output < 30 cc/h at time of randomization
  • Heart failure or pulmonary edema
  • Hypersensitivity to Torsemide or sulfonylureas
  • Hypokalemia (serum potassium < 3 mEq/L)
  • Preexisting diuretic use within 24 hours prior to randomization

Sites / Locations

  • The University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Torsemide

Placebo

Arm Description

Torsemide 20 mg daily for 5 days

Placebo 20 mg daily for 5 days

Outcomes

Primary Outcome Measures

Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg
Persistent postpartum hypertension was defined as sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first.

Secondary Outcome Measures

Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)
Number of Participants Requiring Postpartum Readmission
Length of Hospital Stay After Delivery
Weight Change
Change in Lower Extremity Edema
Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus.
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)
Number of Participants With Side Effects of Therapy - Decreased Breast Milk
Number of Participants With Severe Composite Maternal Morbidity
Severe composite maternal morbidity is defined as having any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy, or maternal death.

Full Information

First Posted
June 19, 2016
Last Updated
March 21, 2019
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02813551
Brief Title
ToRsemide for pOstpartum HYpertension
Acronym
TROPHY
Official Title
Torsemide for the Prevention of Persistent Postpartum Hypertension in Preeclamptic Women: A Randomized, Placebo-Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
September 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently there is no intervention to prevent persistent postpartum hypertension in preeclamptic women. Physiologically, the use of a pharmacokinetically predictable loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the incidence of persistent postpartum hypertension in preeclamptic women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Preeclampsia, puerperium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Torsemide
Arm Type
Experimental
Arm Description
Torsemide 20 mg daily for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 20 mg daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Torsemide
Other Intervention Name(s)
Demadex, torasemide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg
Description
Persistent postpartum hypertension was defined as sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first.
Time Frame
0-5 days after delivery
Secondary Outcome Measure Information:
Title
Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)
Time Frame
0-6 weeks after delivery
Title
Number of Participants Requiring Postpartum Readmission
Time Frame
0-6 weeks after delivery
Title
Length of Hospital Stay After Delivery
Time Frame
0-5 days after delivery
Title
Weight Change
Time Frame
at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
Title
Change in Lower Extremity Edema
Description
Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus.
Time Frame
at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)
Title
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
Time Frame
7-10 days after delivery
Title
Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)
Time Frame
6 weeks after delivery
Title
Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)
Time Frame
0-5 days after delivery
Title
Number of Participants With Side Effects of Therapy - Decreased Breast Milk
Time Frame
0-5 days after delivery
Title
Number of Participants With Severe Composite Maternal Morbidity
Description
Severe composite maternal morbidity is defined as having any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy, or maternal death.
Time Frame
0-6 weeks after delivery
Other Pre-specified Outcome Measures:
Title
Torsemide Concentrations in Breast Milk
Description
Ancillary study
Time Frame
0-5 days after delivery
Title
Electrolyte Profile in Maternal Serum
Description
Concentrations of: Sodium, Potassium, Calcium
Time Frame
0-5 days after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postpartum women at ≥ 18 years of age Antepartum/intrapartum or within 24 hours postpartum diagnosis of either: Preeclampsia Preeclampsia with severe features Preeclampsia superimposed to chronic hypertension Exclusion Criteria: Chronic hypertension without superimposed preeclampsia Gestational hypertension Urine output < 30 cc/h at time of randomization Heart failure or pulmonary edema Hypersensitivity to Torsemide or sulfonylureas Hypokalemia (serum potassium < 3 mEq/L) Preexisting diuretic use within 24 hours prior to randomization
Facility Information:
Facility Name
The University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30303905
Citation
Viteri OA, Alrais MA, Pedroza C, Hutchinson M, Chauhan SP, Blackwell SC, Sibai BM. Torsemide for Prevention of Persistent Postpartum Hypertension in Women With Preeclampsia: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1185-1191. doi: 10.1097/AOG.0000000000002941.
Results Reference
derived

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ToRsemide for pOstpartum HYpertension

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